Effects of concurrent optical and magnetic stimulation in hard-to-heal wounds: a real-world evidence case series.

OBJECTIVE: This work explores concurrent optical and magnetic stimulation (COMS) effects on hard-to-heal wounds in real-world settings. METHOD: In this case series, participants received COMS 1-3 times per week for up to 12 weeks alongside standard wound care. RESULTS: A total of 27 patients (18 female and nine male) were included. Mean age was 72 years. Participants' wounds that were unresponsive to standard wound care included: venous leg ulcers (VLUs, n=13); mixed leg ulcers (MLUs, n=4); diabetic foot ulcers (DFUs, n=1); pressure ulcers (PUs, n=5); and traumatic wounds (TWs, n=4). On average, COMS was applied twice a week, resulting in an overall mean wound area reduction of 69%. In 24 participants, COMS was used primarily to achieve wound closure by the end of the 12-week period, of which: 12 were classified as complete wound closure (50%; VLUs=8, PUs=3 and TW=1); four as likely-to-heal (17%; VLUs=2 and MLUs=2); four as 'improved' (17%; MLU=1, DFU=1 and TWs=2); and four as 'non-responding' (17%; VLUs=3 and MLU=1). The best results were achieved in PUs and VLUs (respectively 100% and 62% categorised as completely healed). When used in participants where its purpose was other than that of achieving wound closure, COMS was successfully used to debride two PUs, and for wound bed preparation in one TW. CONCLUSION: In this case series, COMS showed positive effects and appeared to be beneficial in healing different types of hard-to-heal wounds in community health and homecare settings. Novel COMS therapy aspects emerged: (1) positive outcomes for PU and VLU treatment; (2) COMS as a potential debridement tool when sharp debridement is unfeasible; and (3) COMS as a promising method to prepare wound beds for subsequent skin grafting or skin replacement procedures.

Treatment of bacterially contaminated lower extremity ulcers with a fatty acid-containing wound matrix: a case series.

OBJECTIVE: The aim was to evaluate the effectiveness of a marine omega fatty acid-containing multimodal wound matrix (MWM) in reducing bacterial contamination and supporting wound area reduction (WAR) in patients with hard-to-heal wounds of varying aetiologies. METHOD: A prospective, single-site, pilot case series of patients with hard-to-heal wounds. All wounds were considered non-healing prior to inclusion as they had failed to achieve at least 50% WAR after at least four weeks of standard of care (SoC) treatments. Patients were seen once weekly for wound assessments, matrix application and dressing changes. Baseline and weekly fluorescence images, standard wound images and wound measurements were obtained. RESULTS: A total of three patients, two with venous leg ulcers (VLUs) and one with a diabetic foot ulcer (DFU) were enrolled in this pilot study. The mean baseline wound age prior to study enrolment was 24 weeks, with a mean baseline wound size of 8.61cm2. The two VLUs went on to complete closure. The DFU displayed a total WAR of 53% by six weeks, when the patient was lost to follow-up due to a geographical relocation. The mean percentage area reduction of all wounds combined was 82% upon study completion. CONCLUSION: The use of MWM proved to be effective and safe in this patient cohort. The wounds included in this case series failed to enter a healing trajectory with SoC wound therapies. The MWM supported wound closure and reduced bacterial loads in this patient cohort.

Automated devices for identifying peripheral arterial disease in people with leg ulceration: an evidence synthesis and cost-effectiveness analysis.

Background: Peripheral artery disease is a common condition caused by narrowing/blockage of the arteries, resulting in reduced blood supply. Peripheral artery disease is associated with an increased risk of vascular complications, but early treatment reduces mortality and morbidity. Leg ulcers are long-lasting wounds, usually treated by compression therapy. Compression therapy is not suitable for people with peripheral artery disease, as it can affect the arterial blood supply. In clinical practice, people with peripheral artery disease are identified by measurement of the ankle-brachial pressure index using a sphygmomanometer and manual Doppler device. However, this method can be uncomfortable for people with leg ulcers and automated devices have been proposed as a more acceptable alternative. The objective of this appraisal was to summarise the clinical and cost-effectiveness evidence on the use of automated devices to detect peripheral artery disease in people with leg ulcers. Methods: . Clinical effectiveness: To identify reports of relevant studies, we searched major electronic databases and scrutinised the information supplied by the manufacturers of the automated devices under investigation. Due to the lack of evidence on people with leg ulcers, we considered evidence from studies of any design assessing automated devices versus an acceptable reference device in any population receiving ankle-brachial pressure index assessment. We summarised information on diagnostic accuracy of the automated devices and level of agreement with the reference device. For each device, when data permit, we pooled data across studies by conducting random-effects meta-analyses using a Hierarchical Summary Receiving Operating Characteristics model. Cost-effectiveness: An economic model comprising a decision tree (24 weeks) and Markov models to capture lifetime costs and quality-adjusted life-years associated with venous, arterial and mixed aetiology disease in leg ulcer patients. Analyses were conducted from a United Kingdom National Health Service and Personal Social Services perspective. Costs and quality-adjusted life-years were discounted at 3.5% per year. Deterministic and several probabilistic analyses were used to capture uncertainty surrounding a range of optimistic and pessimistic assumptions about the impact of automated tests on health outcomes (ulcer healing and requirement for invasive management of arterial disease). Results: . Clinical effectiveness: From the 116 records retrieved by the electronic searches, we included 24 studies evaluating five devices (BlueDop Vascular Expert, BOSO ABI-System 100, Dopplex Ability, MESI ankle-brachial pressure index MD and WatchBP Office ABI). Two studies assessing people with leg ulcers found that automated devices often gave higher ankle-brachial pressure index readings than manual Doppler (underestimation of arterial disease). In the 22 studies involving people without leg ulcers, automated devices generally demonstrated good specificity and moderate specificity. Meta-analysis of 12 studies showed a pooled sensitivity of 64% (95% confidence interval 57% to 71%) and a pooled specificity of 96% (95% confidence interval 92% to 98%) for detection of peripheral artery disease. Cost-effectiveness: Automated devices cost less than manual Doppler to deliver. However, increased risks of invasive treatment requirements for inappropriately compressed arterial/mixed ulcers due to false-negative results, and increased healing times due to delayed compression of false-positive test results mean that in most scenarios manual Doppler was less costly and had slightly higher quality-adjusted life-years than automated devices. Results are highly uncertain, dependent on many assumptions and should be interpreted cautiously. Limitations and conclusions: The limited evidence identified for each automated device, especially in people with leg ulcers, and its clinical heterogeneity precludes any firm conclusions on the diagnostic performance and cost-effectiveness of these devices in clinical practice. Study registration: This study is registered as PROSPERO CRD42022327588. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135478) and is published in full in Health Technology Assessment; Vol. 28, No. 37. See the NIHR Funding and Awards website for further award information.

Leg ulcers are long-lasting wounds mostly caused by problems in blood flow in the veins, which are treated by applying bandages or stockings to create a 'compression' effect. However, compression should not be used in people with a condition called peripheral artery disease. To identify people with peripheral artery disease who should not receive compression therapy, health professionals perform a test called 'ankle­brachial pressure index', which involves taking blood pressure of the arms and ankles using a device called 'Doppler ultrasound'. The procedure is time-consuming and people with leg ulcers often find it uncomfortable. Automated devices have been proposed as a more acceptable option for assessing leg ulcers. However, we need to know whether these devices produce reliable results and represent good value for money for the National Health Service. We found 24 clinical studies that assessed 5 automated devices to measure ankle­brachial pressure index. The type of patients and clinical setting varied between studies. Two studies assessed people with leg ulcers and showed that the automated devices tended to give higher readings than standard Doppler and, therefore, may underestimate the presence of peripheral artery disease. Results of the 22 studies assessing people without leg ulcers showed that the automated devices could correctly identify people who did not have peripheral artery disease but were less precise in identifying people with peripheral artery disease. However, there was not enough evidence to confirm if these devices are reliable enough to be used in clinical practice. Compared to manual Doppler, the automated devices were less costly to deliver in clinical practice but had increased costs due to potentially inaccurate results. Our evaluation required many assumptions about how the devices would be used in practice, and there were no data on their impact on patient outcomes. Results are highly uncertain and should be interpreted cautiously. Given current evidence, it is unlikely that automated tests are a convenient option for the National Health Service.

Arterial Leg Ulcers in the Octogenarian.

Arterial leg ulcers are a debilitating sequela of chronic ischemia, and their management, particularly in the octogenarian, is an immense challenge. ALUs are frequently a manifestation of end-stage peripheral arterial disease, and their presence portends a high morbidity and mortality. Management primarily relies on restoration of flow, but in the geriatric population, interventions may carry undue risk and pathologies may not be amenable. Adjunctive therapies that improve quality of life and decrease morbidity and mortality are therefore essential, and understanding their benefits and limitations is crucial in developing a multimodal treatment algorithm of care for the uniquely challenging octogenarian population.

Other Wounds Encountered in Clinical Practice.

This chapter delves into uncommon wounds including pyoderma gangrenosum, sickle cell disease ulcers, vasculitic wounds, Martorell hypertensive ischemic leg ulcers, and malignant ulcers. Emphasizing a multidisciplinary approach, it covers diagnostics, treatments, and challenges, with case studies illustrating complexities in managing these conditions. The discussion extends to radiation-related wounds, underscoring the need for patient-centered care, interdisciplinary collaboration, and realistic goal setting. Overall, the chapter navigates the intricacies of uncommon wounds, emphasizing the importance of tailored approaches for improved outcomes in patients with diverse underlying conditions.

The muscle pump activator device: From evidence to lived experiences.

A chronic wound is one that fails to progress through a normal timely sequence of repair, or in which the repair process fails to restore anatomic and functional integrity after 3 months. The most common chronic wounds include venous, ischaemic and mixed leg ulcers, diabetic foot ulcers and pressure injuries. Chronic wounds place immense physical and psychosocial burden on patients and exact heavy costs for healthcare systems, with many patients continuing to live with chronic wounds even after all management options have been exhausted. The muscle pump activator (MPA) device can be used to bridge this therapeutic gap. By stimulating the common peroneal nerve to activate venous muscle pump of the leg and foot, the MPA device increases blood flow to the lower leg and foot to improve conditions for healing. Currently, evidence in the literature exist to show that the MPA device improves wound outcomes over standard compression therapy, decreases edema and increases wound healing rates. In this review, we also present a series of chronic wound patients treated with the MPA device in multicentre clinics to demonstrate the ability of the MPA device to improve wound outcomes, reduce pain and edema and improve patient quality of life.

Biocellulose-based hydrogel dressing as a strategy for the management of chronic arterial wounds.

PURPOSE: To evaluate using a biocellulose-based hydrogel as an adjuvant in the healing process of arterial ulcers. METHODS: A prospective single group quasi-experimental study was carried out with chronic lower limb arterial ulcer patients. These patients received biocellulose-based hydrogel dressings and outpatient guidance on dressing and periodic reassessments. The primary outcomes were the ulcer-healing rate and product safety, which were assessed by ulcer area measured in photographic records of pre-treatment and posttreatment after 7, 30, and 60 days. Secondary outcomes were related to clinical assessment by the quality-of-life scores (SF-36 and EQ-5D) and pain, evaluated by the visual analogue scale (VAS). RESULTS: Seventeen participants were included, and one of them was excluded. Six patients (37%) had complete wound healing, and all patients had a significant reduction in the ulcer area during follow-up (233.6mm2 versus 2.7mm2) and reduction on the score PUSH 3.0 (p < 0.0001). The analysis of the SF-36 and EQ-5D questionnaires showed a statistically significant improvement in almost all parameters analyzed and with a reduction of pain assessed by the VAS. CONCLUSIONS: The biocellulose-based hydrogel was safe and showed a good perspective to promoting the necessary conditions to facilitate partial or complete healing of chronic arterial ulcers within a 60-day follow-up. Quality of life and pain were positively affected by the treatment.

Advancing nursing practice in Ireland: A pathway of care for nurse-led integrated venous leg ulcer management.

Approximately 80% of patients presenting with leg ulcers are venous in origin. However, lack of standardisation of care has a human and financial impact for patients and service providers. Increases in the aging population and number of patients entering older age with co-morbidities results in increases in the demand for venous leg ulcer treatments. A joint initiative between a Registered Advanced Nurse Practitioner (RANP) in tissue viability and wound care, and a vascular consultant, identified deficits in patient care delivery and quality of life. A joint initiative Implementing the principles of the 'Sláintecare' policy was established as the Leg Ulcer Centre Ireland (LUCI) to deliver a pathway for the treatment and management of lower limb venous ulcers. The RANP provides a "one stop shop" for patients, offering a complete care package from diagnosis to surgical intervention - endovenous ablation, follow-up post operative care and discharge. Audit findings include; reduced hospital admissions and waiting times; increased patient satisfaction; and, improved interdisciplinary integrated referral pathways. The RANP offers an effective, efficient diagnosis-to-end treatment service for patients. The results demonstrate improved treatment, cost outcomes and value-based outcomes for patients. The new integrated service facilitates expansion of the service and further enhancement of the nursing skills and role.

Treatment of vascular leg ulcers with leukocyte- and platelet-rich fibrin (L-PRF): A systematic review.

Objectives: This systematic review aimed to assess the efficacy of Leukocyte- and Platelet-Rich Fibrin (L-PRF) for the treatment of vascular leg ulcers. Method: Following PRISMA guidelines, a literature search was done for studies where L-PRF was used to treat vascular leg ulcers. Results: Among six included articles, a total of 76 venous leg ulcers were treated with L-PRF. None of the studies included ulcers of arterial or lymphatic origin. Fifty-seven (75.0%) of the venous ulcers completely healed at end of follow-up. Mean time to complete healing was 6.7 weeks (SD = 5.0). All non-healed ulcers showed an important reduction in wound area. No adverse effects related to L-PRF therapy were reported. Conclusions: The results suggest that L-PRF could be a safe, simple to use and effective therapeutic option for the treatment of venous leg ulcers, however, caution is advised as the results are based on small sample sizes.

Consistency of wound care in Leg Clubs.

Mr B had lost his wife of 65 years and was distraught, but he tried to move on with life. However, while playing football he injured his leg, which then developed into a venous ulcer that was to last for many years. Unfortunately, his care was inconsistent, and the wound was not progressing. He found the local Leg Club and decided to self-refer. He not only went on to achieve wound closure rapidly, but he found a social atmosphere in the club, made friends and learned how to prevent the wound from recurring. He felt that consistency of care was the reason for the rapid progress.

Treatment of hard-to-heal wounds in ischaemic lower extremities with a novel fish skin-derived matrix.

OBJECTIVE: To evaluate the efficacy of treatment of hard-to-heal wounds of patients with ischaemia of the lower extremities, and compare an omega-3 wound matrix product (Kerecis, Iceland) with a standard dressing. METHOD: A single-centre, prospective, randomised, controlled clinical trial of patients with hard-to-heal wounds following three weeks of standard care was undertaken. The ischaemic condition of the wound was confirmed as a decreased transcutaneous oxygen pressure (TcPO2) of <40mmHg. After randomising patients into either a case (omega-3 dressing) or a control group (standard dressing), the weekly decrease in wound area over 12 weeks and the number of patients that achieved complete wound closure were compared between the two groups. Patients with a TcPO2 of ≤32mmHg were taken for further analysis of their wound in a severe ischaemic context. RESULTS: A total of 28 patients were assigned to the case group and 22 patients to the control group. Over the course of 12 weeks, the wound area decreased more rapidly in the case group than the control group. Complete wound healing occurred in 82% of patients in the case group and 45% in the control group. Even in patients with a severe ischaemic wound with a TcPO2 value of <32 mmHg, wound area decreased more rapidly in the case group than the control group. The proportions of re-epithelialised area in the case and control groups were 80.24% and 57.44%, respectively. CONCLUSION: Considering the more rapid decrease in wound area and complete healing ratio in the case group, application of a fish skin-derived matrix for treating lower-extremity hard-to-heal wounds, especially with impaired vascularity, would appear to be a good treatment option.

[Chronic wounds of the lower limbs: a guide for non-specialists]. / Plaies chroniques des membres inférieurs : un guide pour le non-spécialiste.

Chronic lower-extremity ulcers are a growing public health problem, resulting in significant costs for society and patients, and having a significant impact on the quality of life of patients and informal caregivers. As general practitioners are often solicited early on, the acquisition of basic knowledge regarding wound care management is therefore essential to initiate local care, to make an early diagnosis and identify emergencies and patients that need a referral. The CASE and TIMERS frameworks enable a holistic assessment of the patient and the wound, to propose a treatment of the wound based on its etiology combined with appropriate local wound care. This framework allows also to identify atypical, severe, or recalcitrant wounds requiring specialized advice.

Les plaies chroniques des membres inférieurs sont un problème grandissant de santé publique, occasionnant des dépenses conséquentes et entraînant une répercussion non négligeable sur la qualité de vie des patients et de leurs proches aidants. Les médecins de premier recours étant le plus souvent les premiers intervenants, l'acquisition d'un socle commun de connaissances est donc essentielle pour la bonne prise en soin initiale des plaies chroniques, obtenir un diagnostic précoce et identifier les urgences et les patients à référer. L'approche selon les principes CASE et TIMERS permet une évaluation holistique du patient et de sa plaie, et de proposer un traitement étiologique associé à des soins locaux adaptés. Celle-ci permet également d'identifier les plaies atypiques, sévères ou récalcitrantes, nécessitant un avis spécialisé.

Negative pressure wound therapy with instillation and dwell time in debridement of fibrinous leg ulcers.

OBJECTIVE: In conjunction with appropriate wound care, negative pressure wound therapy with instillation and dwell time (NPWTi-d) may be used as an adjunct therapy for acute or hard-to-heal (chronic) wounds, especially when infected. However, there are very few data on the use of NPWTi-d in the treatment of fibrinous wounds that are difficult to debride mechanically. The main objective of this study was to describe changes in the fibrin area of such wounds, before and after treatment with NPWTi-d. METHOD: This was a monocentric, observational, prospective pilot study evaluating the NPWTi-d medical device. Eligible patients included in the study were those with hard-to-heal lower limb ulcers who had previously undergone unsuccessful specific debridement treatment for their wound, with failure of manual mechanic debridement for at least six weeks' duration, and whose wounds had a fibrinous surface area of >70% of the total wound surface area. The primary endpoint was the difference in the percentage of fibrinous surface area before and after treatment. RESULTS: A total of 14 patients who received treatment for lower limb ulcers between October 2017 and August 2019 were included in the study. There was a significant shrinkage rate of the fibrinous wound surface between the start and end of treatment (83.6±14.5% and 32.2±19.7%, respectively; p<0.001). CONCLUSION: This study showed a significant decrease in fibrin area in wounds treated with NPWTi-d, with good tolerance. We believe that NPWTi-d has its place in the multidisciplinary management of patients with hard-to-heal ulcers. Additional randomised studies are required to confirm these findings. DECLARATION OF INTEREST: The authors have no conflicts of interest.

Molecular characterization of chronic cutaneous wounds reveals subregion- and wound type-specific differential gene expression.

A limited understanding of the pathology underlying chronic wounds has hindered the development of effective diagnostic markers and pharmaceutical interventions. This study aimed to elucidate the molecular composition of various common chronic ulcer types to facilitate drug discovery strategies. We conducted a comprehensive analysis of leg ulcers (LUs), encompassing venous and arterial ulcers, foot ulcers (FUs), pressure ulcers (PUs), and compared them with surgical wound healing complications (WHCs). To explore the pathophysiological mechanisms and identify similarities or differences within wounds, we dissected wounds into distinct subregions, including the wound bed, border, and peri-wound areas, and compared them against intact skin. By correlating histopathology, RNA sequencing (RNA-Seq), and immunohistochemistry (IHC), we identified unique genes, pathways, and cell type abundance patterns in each wound type and subregion. These correlations aim to aid clinicians in selecting targeted treatment options and informing the design of future preclinical and clinical studies in wound healing. Notably, specific genes, such as PITX1 and UPP1, exhibited exclusive upregulation in LUs and FUs, potentially offering significant benefits to specialists in limb preservation and clinical treatment decisions. In contrast, comparisons between different wound subregions, regardless of wound type, revealed distinct expression profiles. The pleiotropic chemokine-like ligand GPR15L (C10orf99) and transmembrane serine proteases TMPRSS11A/D were significantly upregulated in wound border subregions. Interestingly, WHCs exhibited a nearly identical transcriptome to PUs, indicating clinical relevance. Histological examination revealed blood vessel occlusions with impaired angiogenesis in chronic wounds, alongside elevated expression of genes and immunoreactive markers related to blood vessel and lymphatic epithelial cells in wound bed subregions. Additionally, inflammatory and epithelial markers indicated heightened inflammatory responses in wound bed and border subregions and reduced wound bed epithelialization. In summary, chronic wounds from diverse anatomical sites share common aspects of wound pathophysiology but also exhibit distinct molecular differences. These unique molecular characteristics present promising opportunities for drug discovery and treatment, particularly for patients suffering from chronic wounds. The identified diagnostic markers hold the potential to enhance preclinical and clinical trials in the field of wound healing.

Diagnosing and Managing Venous Stasis Disease and Leg Ulcers.

Venous insufficiency is a common medical condition that affects many individuals, especially those with advanced age. Chronic venous insufficiency can lead to secondary cutaneous changes that most commonly present as stasis dermatitis but can progress to more serious venous ulcers. Although venous ulcers are the most common cause of lower extremity ulcers, the differential diagnosis of leg ulcers is broad. This article will discuss clinical clues to help guide patient workup and will review basic clinical evaluation and management of common leg ulcers.